News & Analysis as of

Warning Letters Food and Drug Administration (FDA) Department of Health and Human Services (HHS)

Skadden, Arps, Slate, Meagher & Flom LLP

Joint FDA/HHS Initiative Targeting Direct-to-Consumer Pharmaceutical Advertising Garners Much Attention, but Legal Basis and...

On September 9, 2025, the Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) announced a new initiative to close what the agencies describe as a “loophole” in requirements regarding the...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Vast Ad/Promo Warning – Enforcement Ramp-Up or PR Nothingburger?

Late Tuesday, FDA issued a press release warning that it would be sending “thousands of letters warning pharmaceutical companies to remove misleading ads and issue approximately 100 cease-and-desist letters to companies with...more

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Morrison & Foerster LLP

How FDA Is Monitoring The COVID-19 Product Market

FDA is actively “monitor[ing] the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic.” The agency says it has discovered hundreds of fraudulent COVID-19 products,...more

McGuireWoods LLP

FDA’s Dual Approach to Enforcing Federal Food, Drug, and Cosmetics Act During COVID-19 Crisis

McGuireWoods LLP on

The COVID-19 pandemic has brought a cascade of statements from the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS). Below are summaries of some of the more pertinent statements...more

BakerHostetler

BakerHostetler FDA and Pharmacy Weekly Digest

BakerHostetler on

Last week Health and Human Services (HHS) released its Statement of Regulatory Priorities for Fiscal Year 2019. Several of the FY19 priorities include: (1) combatting the opioid crisis; (2) strengthening individual health...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - June 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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